Gastric band

ABSTRACT

A gastric band of a belt type is presented for attaching around a circumference of a patient&#39;s stomach, so as to define the diameter of the stomach opening. The band comprises outer and inner surfaces, wherein the inner surface engages the stomach, and at least the outer surface is formed by an elongated member substantially non-extendable along a longitudinal axis thereof. A through-going opening is made in the elongated member and is located so as to define an end portion of the band having a predetermined length. An opposite end portion of the band is shaped so as to be insertable into the through-going opening for adjusting a desired inner diameter of the band in its closed operating position and fastening the opposite end portion to the outer surface of the band.

FIELD OF THE INVENTION

This invention relates to a gastric banding device that encircles a portion of the stomach to form a stoma opening of reduced diameter.

BACKGROUND OF THE INVENTION

Morbid obesity is associated with medical risks in terms of the development of additional diseases such as diabetes, hypertension, cardiac insufficiency and other socio-psychological problems, overall reducing life expectancy. Dietary management, psychiatric or dietary regiments are the first choice for treating morbid obesity, but as they depend on the goodwill of the patient, especially in the long run, these approaches often fail.

Various surgical approaches have been developed and used for treating morbid obesity. These include gastric bypasses, small bowel bypasses and stapling of portions of the stomach. The stapling techniques include horizontal and vertical stapling for reducing the volume of the stomach, as well as narrowing the stoma opening thus controlling the food intake of the stomach. However the latter approach, stapling, may not bring the desired results due to the fact that the staples frequently open or tend to cause perforations. Furthermore the stomach opening formed by staples widens over time, thus the effect is reduced or even eliminated.

A different approach to the problem specified above is described in U.S. Pat. No. 4,416,267, which discloses a method for treating obesity by placing an inflatable balloon into the stomach. Such a device displaces volume inside the stomach, thereby reducing the effective free volume of the gastric portion causing the individual to feel no need for additional food intake. The balloon is inflated in the stomach to a predetermined volume and is left there for a certain period of time after which it is easily removed. However, this procedure although being physically easy to implement and basically being non-surgical, may lead to harmful results. The inflated balloon in the stomach is in constant contact with gastric mucous, and such contact for an extended period of time may give rise to gastric ulcers and intestinal blockage.

Recently, another approach has been developed based on placing a physical means (i.e. a gastric band) outside the stomach. A gastric band is placed around the upper part of the stomach, thereby creating an altered stomach opening of a reduced diameter, resulting in the restriction of food intake into the digestive portion of the stomach. Such a gastric-banding technique is simple as compared to the above-mentioned balloon-based technique. However, this band has no means for adjusting its diameter to obtain the optimal diameter of the stomach opening.

Adjustable gastric bands have been developed, and disclosed for example in U.S. Pat. No. 4,592,339, as well as in “A Gastric Band with Adjustable Inner Diameter for Obesity Surgery”, P. Forsell et al., Obes Surg., 1993, No. 3, pp. 303-306. According to this technique, the diameter of a belt-like band, when in a closed position thereof, may be adjusted. For this purpose, the band includes an inflatable portion in its interior part. Controllable inflating and deflating of this portion alters the stomach opening. Although this gastric band can retain the predetermined diameter of the stomach opening, obtaining of the proper opening is somewhat problematic.

U.S. Pat. No. 4,696,288 discloses a calibrating apparatus for using with, a gastric band for controlling the diameter of the stomach opening by regulating the band's diameter. Such a gastric band is typically mounted with a laproscopic technique, disclosed for example in U.S. Pat. No. 5,226,429.

SUMMARY OF THE INVENTION

It is a main object of the present invention to provide a gastric band of a belt type, which can be attached to a patient's stomach in a safe manner and without damaging the stomach circumference.

It is a further object of the present invention to provide such a band which can be easily mounted on the stomach utilizing a laproscopic technique.

It is a still further object of the present invention to provide such a band that is easily enables its facile detectable by any suitable imaging means, thereby facilitating access to the band when additional surgical/laproscopic intervention is desired.

There is thus provided according to one aspect of the present invention, a gastric band for attaching around a circumference of a patient's stomach so as to define the diameter of the stomach opening, the band comprising:

(a) outer and inner surfaces, wherein the inner surface engages the stomach, and at least the outer surface is formed by an elongated member substantially non-extendable along a longitudinal axis thereof;

(b) a through-going opening made in said member and located so as to define an end portion of the band having a predetermined length; and

(c) an opposite end portion of the band shaped so as to be insertable into said through-going opening for adjusting a desired inner diameter of the band in its closed operating position and fastening the opposite end portion to the outer surface of the band.

The gastric band is of a belt type, and also comprises a suitable fastening means, which may utilize a required number of stitches or the provision of bolt-and-nut arrangements on the band. The fastening means may also be in the form of teeth-like edges of the opposite end portion and a correspondingly shaped through-going opening.

The outer and inner surface may be formed either of the same material, or of different materials, provided that the material of the outer surface is substantially not-extendable.

Preferably, at least the outer surface of the band is made of poly-tetra-fluoro-ethylene, known as Gortex. The material of the inner surface of the band engaging the stomach may be silicone. The band, when in the operation position thereof is such that its inner surface engaging the stomach has a substantially circular shape.

The predetermined length of the end portion is such as to enable the detection of the gastric band by a laproscopic inspection tool.

According to another aspect of the present invention, there is provided a system for laproscipically attaching a gastric band around a patient's stomach so as to define a certain diameter of the stomach opening, the system comprising a calibration device which is insertable into the stomach at a predetermined depth and comprises:

an upper portion having variable volume, and a lower projection-like portion having a diameter substantially equal to

said certain diameter of the stomach opening to be defined by the band, the location of said projection-like portion when in the inserted position of the calibration device defining the location of the band with respect to the stomach; said band comprising: outer and inner surfaces, wherein the inner surface engages the stomach, and at least the outer surface is formed by an elongated member substantially non-extendable along a longitudinal axis thereof; a through-going opening made in said member and located so as to define an end portion of the band having a predetermined length; and an opposite end portion of the band shaped so as to be insertable into said through-going opening for adjusting a desired inner diameter of the band in its closed operating position and fastening the opposite end portion to the outer surface of the band.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be carried out in practice, a preferred embodiment will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

FIGS. 1 a and 1 b are schematic illustrations of a gastric band in its open and closed positions, respectively, constructed according to one embodiment of the invention;

FIG. 2 schematically illustrates the band of FIGS. 1 a and 1 b in its operation position being attached to the patient's stomach;

FIGS. 3 a and 3 b are schematic illustrations of a gastric band in its open and closed positions, respectively, constructed according to another embodiment of the invention;

FIGS. 4 a and 4 b are schematic illustrations of a gastric band in its open and closed positions, respectively, constructed according to yet another embodiment of the invention;

FIGS. 5 a and 5 b are schematic illustrations of a gastric band in its open and closed positions, respectively, constructed according to yet another embodiment of the invention;

FIGS. 6 a and 6 b schematically illustrate two steps of a calibration procedure carried out prior to mounting the band on the stomach; and

FIGS. 7 a to 7 f illustrates five sequential steps, respectively, of mounting the band of FIGS. 3 a-3 b onto the patient's stomach.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

Referring to FIGS. 1 a and 1 b there is illustrated a gastric band, generally designated 1, constructed according to one embodiment of the invention. The band is typically an elongated strap having two opposite end portions 1 a and 1 b. The portion 1 b is substantially cone shaped, while the end portion 1 a is formed with a through-going, substantially elliptically-shaped opening 4 displaced from the corresponding butt-end of the band 1 by a certain length L.sub.0, the purpose of which will be described further below. For example, the band's dimensions may be as follows:

1) the length L.sub.1 of the entire band is about 15 cm;

2) the length L.sub.0 is about 3 cm;

3) the width h.sub.0 of the band is 2 cm;

4) the thickness h.sub.1 of the band is 2 mm; and

5) the long axis L.sub.2 of the opening 4 is about 1-7 mm.

As clearly seen in FIG. 1 b, the band 1 has outer and inner surfaces 2 a and 2 b, respectively. To attach the band 1 around a stomach (not shown here), the cone shaped end portion 1 b passes through the opening 4, and is fastened along a corresponding location on the band by a suitable fastening means, for example by stitches 6. Thereafter, the free part of the end portion 1 b is cut off by any suitable means, as shown in a dashed line. The opposite end portion 1 a, whilst being optionally partly stitched to the band 1, extends away therefrom. The band 1 is made of a polymer material, which is substantially non-extendable along its longitudinal axis. For example, poly-tetra-fluoro-ethylene (i.e. Gortex) can be used for manufacturing the band 1.

Turning now to FIG. 2, there is illustrated that, when in the operative position of the band 1 being attached around a stomach 10, the free end portion 1 a protrudes from the band. It will be readily understood that such a protrusion would be easily detected by any suitable imaging means. This is a very important feature facilitating the access to the band when additional surgical/laproscopic intervention is desired

As further seen in FIG. 2, the band 1 actually defines two portions 10 a and 10 b of the stomach 10, and defines the diameter of a so-called stomach opening (not seen here) underneath the band 1. The portions 10 a and 10 b are fastened to each other by stitches 12 or the like within the vicinity of the band 1, thereby fixing its relative location on the stomach. It should be noted that stitches 6, as well as the stitches 12, may be replaced by any other suitable fastening means.

Reference is made to FIGS. 3 a and 3 b, illustrating a gastric band 14 in its opened and closed positions, respectively. The band 14 has somewhat different construction as compared to the band 1. To facilitate understanding, same reference numbers are used for identifying those components, which are identical in the bands 1 and 14. Here, at least one so-called “bolt-and-nut” arrangement is provided serving as the fastening means. To this end, as shown in the figures in a self-explanatory manner, spaced-apart mushroom-like bolts, generally at 16, project upwardly from the upper surface 2 a. Consequently, holes 18 (four in the present example) are aligned along the longitudinal axis of the band in a spaced-apart parallel relationship. The diameter of the hole 18 corresponds to that of the head portion of the mushroom-like bolt 16 to put the bolt-and-nut arrangement into its engaged position, thereby closing the band.

In this specific example, the bolts 16 project from a plate-like support 20, forming together an integral assembly, generally designated 22. The assembly 22 is attached to the upper surface 2 a of the band 14 by stamping. The entire band, except for the assembly 22, may be made of a polymer material like Gortex, while the assembly 22 may be made of a substantially rigid silicone. The bolts 16 (and consequently two locally adjacent holes 18) are spaced from each other by the length L.sub.4 of about 7 mm, the dimensions of the plate 20 being as follows: the length L.sub.3=2 cm, and the width h.sub.3=12 mm. As shown in FIG. 3 b, after closing the band on the patient's stomach, two stitches 24 (or the like) are provided to ensure the fixed diameter of the band, and thereby of the stomach opening. Similarly to the previously described embodiments, the corresponding part of the end portion 1 b is cut off, while the opposite part 1 a protrudes from the band to be detectable.

FIGS. 4 a and 4 b illustrate a gastric band, generally at 26, according to yet another embodiment of the invention. Similarly, same reference numbers are used for identifying those components, which are identical in the bands 1, 14 and 26. The band 26, in distinction to the bands 1 and 14, has its inner surface 2 b formed of a relatively flexible material relative to that of the outer surface. For example, this may be implemented by coating a center part of the inner surface of the band 26 with silicone. As for the outer surface 2 a of the band 26, as well as the inner surface thereof within the end portions, they are made of a substantially non-extendable material. The end portion 1 a should be made of such a non-extendable material which is not too rigid in order not to harm the stomach, e.g. Gortex.

FIGS. 5 a and 5 b illustrate yet another construction of a gastric band 27 using the same reference numbers for identifying the common elements in the bands 1, 14, 26 and 27. In the band 27, similar to the band 26, the center part of its inner surface is formed with a substantially flexible material, e.g. flexible silicone, while the end portions are made of a non-extendable material. As for the fastening means, in the band 27 the end portion 1 b is formed with teeth-like edges 16′. Consequently, a through-going opening 4′ is shaped in a manner to define a slot 18′ allowing a forward movement of the portion 1 b through the opening 4′, but preventing its sliding back out of the opening 4′ in the operating (closed) position of the band 27. To this end, the center part of the outer surface 2 a, as well as the end portion 1 b, are made of a substantially rigid material, e.g. rigid silicone. As indicated above, the opposite end portion 1 a should be made of a substantially flexible material.

Reference is now made to FIGS. 6 a and 6 b illustrating two steps of a typically performed calibration stage for determining the desired diameter of the stomach opening and defining its location to mount a gastric band there. To this end, a calibrating device, generally designated 28, is used. The construction and operation of such a calibration device are known per se, and therefore need not be described in detail, except to note the following. The device 28 comprises an upper, balloon-like portion 28 a associated with a suitable pump, which is not specifically shown, and a lower projection 28 bb having a substantially circular cross-section of the desired diameter D.sub.0.

Upon inserting the device 28 inside the stomach 10 through a stomach inlet 29, the balloon-like portion 28 a is inflated up to the volume V.sub.1 corresponding to the diameter D.sub.1 of the portion 28 a, so as to substantially engage the inner circumference of the stomach 10. This maximum diameter D.sub.1 of the portion 28 a is determined in accordance with the inflating pressure.

Thereafter, the device is partially deflated to such a volume V.sub.2 that corresponds to the diameter D.sub.2 of the portion 28 a, and pulled upwardly up to the inlet 29. Such a position of the device 28 having the known diameter D.sub.2 of its balloon-like portion 28 a actually allows for locating the projection 28 b, thereby defining the location for mounting the gastric band. The calibrating device 28 also comprises a pipe 30 installed thereinside, serving for aspirating the stomach contents and checking whether the mounting of the band caused any damage to the stomach itself, as will be described more specifically further below with reference to FIG. 7 f.

Referring to FIGS. 7 a to 7 f, there are illustrated the main operational steps for laproscopic mounting of the gastric band, for example constructed as described above with reference to FIGS. 3 a and 3 b, on the patient's stomach. As indicated above, the position of the projection 28 b defines the exact location for mounting the band. Hence, it defines the convenient locations for cuttings 32 a and 32 b to be made in the stomach connecting tissue 32 at opposite sides of the stomach 10. An articulated gripping device 34 is typically used for mounting the gastric band on the stomach 10. FIG. 7 a illustrates that the articulated gripping device 34 is sequentially pushed through the openings 32 b and 32 a, to clamp the cone shaped end portion 1 b of the band 14. Then, by pulling the device 34, the band is threaded through the openings 32 a and 32 b, thereby engaging the back-side of the stomach (FIG. 7 b).

This having been done, a pair of gripping devices 36 and 37 are used for supporting the end portion 1 a of the band, while the device 34 passes through the opening 4 and proceeds towards the cone shaped portion 1 b (FIG. 7 c). As shown in FIGS. 7 d and 7 e, by manipulating the gripping devices 36 and 37, the cone shaped end portion 1 b is threaded through the opening 4 and pulled to close the band in a manner described above with reference to FIGS. 3 a and 3 b. The closed operating position of the band is illustrated in FIG. 7 f.

After completing the mounting of the gastric band 14, a pair of stitches 24 are provided and, optionally, depending on the desired diameter, the end portion 1 b is partly cut off. To check whether the entire operation did not damage the stomach and did not completely block the stomach opening, the following procedure is carried out. After the total deflation of the balloon 28 a (through a suitable pump-valve assembly 38) and pulling of the calibrating device 28 upwardly towards the upper part of the paunch, a colored liquid is injected into the pipe 30 through an upper opening 39 of the device 28. It will be readily understood that the non-passage of this liquid into the stomach through the lower end of the pipe 30 indicates of the blockage of the stomach opening. Likewise, any dripping of the colored liquid out of the stomach would indicate of the dangerous condition of stomach perforation, which should immediately be treated.

Those skilled in the art will readily appreciate that various modifications and changes can be applied to the invention as hereinbefore exemplified without departing from its scope defined in and by the appended claims. For example, the gastric band may have any appropriate dimensions, providing it is capable of providing the desired diameter of the stomach opening and its free end portion is detectable by a suitable imaging system. 

1-15. (canceled)
 16. A non-inflatable gastric band comprising: (a) an elongated strip made of soft material substantially non-extensible longitudinally having outer and inner surfaces, wherein the inner surface engages the stomach when in an operating opposition of the band mounted on the stomach; (b) a through-going opening in said band at a location spaced from a butt-end of the band a predetermined distance to define an extended end portion of the band having a predetermined length such that when the band is closed, said end portion freely protrudes of the band; (c) an opposite end portion of the band shaped so as to be insertable into said through-going opening for adjusting a desired inner diameter of the band in its closed operating position and fastening the opposite end portion to the outer surface of the band upon establishing the desired diameter, wherein said extended end portion and the opposite portion serving for gripping the band while mounting it onto the stomach and adjusting the diameter of the band to bring it into its operating closed position, said extended free protruding and portion or the of the band enabling detection of the band while in the operative position thereof mounted on the stomach and enabling gripping the band for readjusting the diameter of the stomach opening after the band is brought into its operating position; wherein the gastric band mounts on the outside of a patient's stomach so as to fix a desired diameter of the band in it operating closed position as defined by a separate calibrating device thereby to determine the diameter of the stomach opening and a volume the stomach above the band; and wherein the two ends of the band are fastened together when the band is in the operating position around the stomach.
 17. The gastric band according to claim 16, further including a fastener comprising at least one projection located on the outer surface of the band, and at least one through-going hole for receiving said at least one projection, when the band is in the operating position around the stomach.
 18. The gastric band according to claim 16, wherein the two ends of the band are fastened together by two or more stitches when the band is in the operating position around the stomach.
 19. The gastric band according to claim 16, wherein the outer and inner surfaces are formed of different first and second materials, respectively.
 20. The gastric band according to claim 19, wherein said second material comprises silicone.
 21. The gastric band according to claim 20, wherein said first material comprises poly-tetra-fluoro-ethylene.
 22. The gastric band according to claim 16, wherein said inner surface engaging the stomach has substantially circular shape when in the operating position of the band.
 23. The gastric band according to claim 16, wherein said predetermined length of the end portion is such as to enable the detection of the gastric band by a laparoscopic inspection tool.
 24. A system for laparoscopically attaching the gastric band of claim 16 around a patient's stomach so as to define a certain diameter of the stomach opening, the system comprising: a calibration device which is insertable into the stomach at a predetermined depth and three articulated gripping devices, wherein the calibration device comprises: an upper portion having variable volume, and a lower projection-like portion having a diameter substantially equal to said certain diameter of the stomach opening to be defined by the band, and further comprising a pipe providing access to the interior of the stomach, wherein the location of said projection-like portion when in the inserted position of the calibration device defines the location of the band with respect to the stomach;
 25. A system according to claim 24 wherein the lower projection-like portion is a rigid tube of fixed diameter.
 26. A system according to claim 24 wherein the pipe extends through the lower projection-like portion for aspiration of the contents of the stomach.
 27. A method for attaching the gastric band of claim 16 around a circumference of a patient's stomach so as to define a desired diameter of the stomach opening and a desired volume of the stomach above the opening, the method comprising: performing a calibration with a calibration device having a balloon-like inflatable upper portion and a lower substantially rigid projection-like portion having a fixed diameter substantially equal to said desired diameter of the stomach opening and to define a plane of location where the gastric band is to be attached, thereby defining the volume of the stomach above the opening, the calibration comprising: inserting the calibration device inside the stomach though a stomach inlet, inflating the upper inflatable portion up to a volume corresponding to a certain maximal diameter thereof so as to substantially engage the inner circumference of the stomach; partially deflating said portion to a volume corresponding to the diameter of the upper portion; and pulling the calibration device towards the stomach inlet to thereby locate the lower portion and define the location for mounting the gastric band; and laparoscopically attaching the gastric band around the circumference of the patient's stomach at said location.
 28. The method of claim 27 wherein attaching the gastric band comprises: inserting a gripping device through cuttings made in the stomach connecting tissue on opposite sides of the back of the stomach in the plane of location of the gastric band; clamping the opposite end portion of the band; and pulling the gripping device to thereby thread the band through the cuttings to engage the back side of the stomach; supporting the end portion of the band while passing the gripping device though said though-going opening of the band towards said opposite end portion of the band; manipulating arms of the gripping device to thread said opposite end portion of the band through the through-going opening and close the band tight around the lower projection-like portion of the calibration device inside the stomach; holding together the end portions of the band by two arms of the gripping device and fastening the opposite end portion to the outer surface of the band; and cutting off a free part of the opposite end portion of the band.
 29. A method of using a band having outer and inner surfaces and first and second ends, a through-going opening in the band spaced from the first end of the band a predetermined distance to define an extended end portion of the band of a predetermined length, the second end of the band being shaped to be insertable into said through-going opening, the method comprising: encircling the band at a position intermediate upper and lower ends of a stomach with the inner surface in contact with the stomach; inserting the second end of the band in the through-going opening, wherein the distance of insertion corresponds to a desired diameter of the stomach opening and a desired volume of the stomach above the opening; and fastening the first and second ends of the band together.
 30. The method of claim 29, further including cutting off a free part of the opposite end portion of the band.
 31. The method of claim 29, wherein encircling the gastric band around the stomach comprises: making cuttings in the stomach connecting tissue on opposite sides of the back of the stomach in a desired location of the gastric band; threading the band through the cuttings to engage the back side of the stomach; and positioning the two ends of the band at the front of the stomach for insertion of the second end portion in the through-going opening.
 32. The method of claim 29, wherein the distance of insertion is determined by pulling the second end of the band until the band is tight around a fixed-diameter portion of a calibration device inserted inside the stomach. 